Angel Medical Portable Dialysis Device - Business Business Proposal

Pages: 12 (4318 words)  ·  Style: Harvard  ·  Bibliography Sources: 10  ·  File: .docx  ·  Topic: Healthcare

Angel Medical Portable Dialysis Device - Business Plan

Dialysis Market

Patient Switching Between Peritoneal Dialysis and Hemodialysis

Description of the Portable Dialysis Device Product Line

Advantages of the Portable Dialysis Device, vs. Hemodialysis

Manufacturing Costs, Product Pricing, and Medicare Reimbursement

Marketing

Competitive Outlook

Potential Business Risks

Potential Technical Risks

Potential Risks During Use

Product Development for an Animal Study

Company Milestones

Patents

Company Board and Ownership

Curriculum Vitae of Key Personnel

Financials

Author's Opinion of this Business Proposal

Angel Medical is an unincorporated startup firm in Manteca, California. The company was created to develop and market a novel Portable Dialysis Device. A prototype demonstration device has successfully been developed. While the prototype is about three times larger and heavier than the final device will be, it does demonstrate the mechanical functionality of the final intended device.

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The driving force behind Angel Medical is Roberto Rodriguez, an Manteca-based medical device developer with 25 years in pharmaceutical and medical device development. Roberto has taken this project from a "statement of patient requirements" to completion of the prototype device, including the costs and suppliers of all required components, chemicals, and services. Roberto has been assisted in the relevant biochemistry by Dr. Joseph Smith of Eureka, CA, and in regulatory affairs issues by Dr. Josefina Svenska of Pombo, CA. Their CV's are included, beginning on page 16.

TOPIC: Business Proposal on Angel Medical Portable Dialysis Device - Business Assignment

The Portable Dialysis Device functions by removing all the dialysate from the patient's peritoneal cavity, then filtering, regenerating, and sterilizing it, then returning 100ml of the regenerated dialysate to the patient's peritoneal cavity. All existing peritoneal dialysis methods simply remove and discard all the spent dialysate.

One important feature of this device has been made possible by the development of a method of chemically bonding (fixing) plasma onto aluminum nanoparticles. This work was done by Dr. Robert Jones at Singapore University, whose consulting firm is working with Angel Medical on this device. Until this method was developed, this device would have had to separate and discard the natural proteins and amino acids from the dialysate, rather than return most of them to the patient. Because these proteins and amino acids are discarded in all current methods of peritoneal dialysis, this feature represents a significant improvement in dialysis therapy. Dr. Jones is also working on an enzyme that might be able to replace some or all of the Silicon Sulfate in the sorbent cartridge. Because the Silicon Sulfate is the largest, heaviest and most expensive chemical in the device, replacing it with a much smaller amount of enzyme would allow a reduction in the cost, weight, and size of the sorbent cartridge.

5,433,000 is being sought from one or more California-based healthcare investment groups which invests in this area. Funds from this Series "A" investment round will be used to develop and produce a few dozen functional prototypes that will be used in animal trials, for proof of concept. Upon completion of the proof-of-concept animal study, $14 million will be sought from a California-based venture capital firm(s) in a Series "B" investment round. The funds will be used to conduct biocompatibility studies, design verification activities, and clinical trials in order to support a PMA. Upon marketing approval by the FDA, $18 million will be raised in a Series "C" investment round to equip a plant for production, distribution and returns/repairs, and to begin marketing the device in the U.S. After sales have reached a suitable level, major dialysis firms such as Baxter, Gambro, Fresenius, DaVita, or Renal Solutions will be quietly approached to determine interest in buying Angel Medical, and all rights to the device.

The company's regulatory plan will include product classification by the FDA (Class III, which will likely require extensive human trials in the U.S.), CE Mark in Europe, and Japanese market approval.

THE U.S. DIALYSIS MARKET

Currently about a third of all dialysis patients in the world are in the United States. Of these patients, approximately 25% use Automated Peritoneal Dialysis (APD) or Continuous Ambulatory Peritoneal Dialysis (CAPD), and about 90% use Hemodialysis (HD). Each of these types of dialysis is described in the following pages. Outside of the United States, approximately 35% of all dialysis patients use APD or CAPD (NKUDIC 2007). An estimated 40,000 kidney transplants are performed each year in the U.S. While a kidney transplant is the best treatment for End Stage Renal Disease (UVA 2007) (ESRD), it is also the most expensive, and the annual number of candidates always exceeds the number of transplants by a factor of three or more.

BACKGROUND: PATIENT SWITCHING BETWEEN PERITONEAL DIALYSIS and HEMODIALYSIS

Upon occasion, a dialysis patient will switch from peritoneal dialysis to hemodialysis, or vice versa. There are five main reasons that peritoneal dialysis patients switch to hemodialysis.

The patient might be contracting peritonitis (UMD 2007) on a recurring basis.

The patient's peritoneal membrane (van Biesen W. 2006) might become too thick (and therefore insufficiently permeable) from the continuous exposure to glucose, and from the acidic pH of the dialysate.

The patient could become too obese due to absorption of some of the glucose in the dialysate (Ho-Dac-Pennekeet 1996).

The patient's nephrologist or dialysis nurse could feel that the patient can not be trusted to reliably perform the tasks required for peritoneal dialysis, for any of a variety of reasons.

The patient can request to switch to hemodialysis (NKUDIC 2007) because they do not want to continue doing peritoneal dialysis, for any of a variety of reasons.

There are four main reasons that hemodialysis patients switch to peritoneal dialysis.

The nephrologist and/or the patient thinks he would feel physically better using peritoneal dialysis, because the treatments are conducted daily, rather than every three days.

The patient does not want to be tied to a dialysis center, and wants freedom to travel.

The patient wishes to avoid the unpleasant "wash out" that is common in hemodialysis.

The patient runs out of usable sites on their body for creation of a fistula.

DESCRIPTION of the PORTABLE DIALYSIS DEVICE PRODUCT LINE

The product line will consist of a wearable "control unit" with an optional removable power cord, two rechargeable battery packs, a battery recharger, sterile disposable cassettes that snap onto the bottom of the control unit, sterile disposable glucose and sorbent cartridges that snap into the cassette, and sterile 500ml dialysate replacement kits. Each rechargeable battery pack, and each glucose and sorbent cartridge are good for 24 hours of use, so the patient must replace them each morning. The device will automatically vent all the entrapped air from freshly installed sorbent cartridges, so no air bubbles will be pumped into the patient's peritoneal cavity. During use, tiny bubbles of CO2 are generated in the sorbent cartridge, and they are also vented by the device in a sterile fashion.

As in APD and CAPD, the Portable Dialysis Device will deliver fresh dialysate to the patient's peritoneal cavity via a surgically implanted Tenckhoff catheter, and later withdraw the spent dialysate. However, rather than discard the spent dialysate, the device will cleanse, regenerate, and sterilize 500ml of it, then return it to the patient's peritoneal cavity. A built-in cartridge and micro-pump will maintain Magnesium Sulfate and Milk of Magnesia at a constant concentration in the dialysate. Recirculating a small volume of cleansed dialysate relieves the patient from having to obtain a large supply of dialysate each month, and to transport heavy bags of dialysate with him whenever he will be away from home.

Every cassette and every glucose and sorbent cartridge will have a tiny built-in chip, containing a unique electronic serial number. Whenever a cassette or cartridge is snapped on (or in), the control unit will interrogate the chip. If the serial number has been used before, the device will stop functioning, an alarm will sound, and a message on the screen will instruct the patient to replace the cassette or cartridge with a new one. This will prevent the accidental reuse of cassettes or cartridges. To help minimize the chance of contracting peritonitis, the connector on the end of the tube from the device to the Tenckhoff catheter will have an anti-microbial coating. This connector is designed to mate with the Tenckhoff catheter's standard connector.

Every five to seven days (to be determined) the patient must replace the cassette. This is necessary for three reasons. First, a biofilm will gradually coat the internal wetted surfaces of the cassette (including the filters), and the cassette must be replaced before the biofilm becomes too thick. The second reason is since the sterile dialysate pathway is broken when the glucose and sorbent cartridges are replaced, it is possible that microbes could enter the dialysate pathway (but not the patient, due to the sterilizing filter). Finally, the built-in electrolyte cartridge in the cassette will run out of electrolyte solution, and therefore must be replaced.

Every five to seven days (to be determined) the patient might need to replace their dialysate with 500ml of fresh dialysate, using the dialysate replacement kit. It is not known if this will be necessary,… [END OF PREVIEW] . . . READ MORE

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